Job Description
Are you a senior engineer who thrives at the intersection of mechanics, electronics and software? Do you enjoy owning complex systems end-to-end and providing technical leadership in highly regulated environments? Then this role could be your next step.
Your Role
As Senior System Engineer, you act as the technical lead and system owner for advanced upper-limb bionic products. You are responsible for the overall technical integrity of the system, ensuring that all disciplines work together toward a common, well-defined technical vision.
You take ownership of the system throughout the entire development lifecycle — from early concept development and requirements definition through detailed design, verification, validation and delivery. In this role, you translate user needs and stakeholder input into clear, traceable system and technical requirements, while continuously balancing performance, safety, reliability, risk and feasibility.
Reporting directly to the Director of Upper Limb Bionics R&D, you operate with a high level of autonomy and authority. You actively connect mechanical, electrical and software teams, guide technical decision-making, assess trade-offs, and ensure alignment with medical device regulations and engineering best practices. You also serve as a key technical reference for change management, risk analysis and system-level decision making throughout development.
What You’ll Do
* Lead the technical direction of complex medical device systems
* Define, document and manage system and product requirements, ensuring full traceability
* Translate high-level needs into detailed technical requirements and system architecture
* Optimize overall system design for performance, safety, reliability and maintainability
* Drive cross-functional alignment across mechanical, electrical and software teams
* Lead risk management activities (FMEA, Fault Tree Analysis, Hazard Analysis)
* Own the Design History File (DHF) / Technical File and change control process
* Guide verification, validation and clinical testing strategies
* Ensure compliance with medical device standards and regulations (MDR, ISO 13485, ISO 14971, IEC 60601-1)
What You Bring
* Engineering degree (Systems, Mechanical, Electrical, Software or Biomedical); advanced degree preferred
* Experience in regulated industries, ideally medical devices
* Strong expertise in one engineering discipline with solid understanding of the others
* Proven experience as a Systems Engineer or Technical Lead
* Ability to work autonomously and make balanced technical decisions
* Strong communication skills, able to translate complex topics for diverse audiences
Why Join Us
You’ll work on life-changing bionic technologies, with real ownership, high autonomy and direct impact. This is a senior, influential role where your technical judgment truly shapes the product — and the lives of the people who use it.